As Dr.
writes about in this Substack, the FDA finally got around to doing some post-market surveillance on the COVID jabs. Here are the notes I took from data found in their data supplement which, as far as I can tell, always used one-sided intervals at 99% confidence:[click image to enlarge]
If the interpretations above are correct, and they seem to be, then that means that the pulmonary embolism signal was present before March of 2021 — though the FDA study wasn’t initially submitted for publication until May of 2022.
By 1 May 2021, the 99% lower bound primary estimate of excess cases of pulmonary embolism in elderly which have at least temporal association with the Pfizer jabs was 1,200 excess cases of pulmonary embolism.
That’s not the central estimate of the excess, it’s the lower bound of the excess. The overall rate per million doses for pulmonary embolism in the elderly, not the excess, was 371 pulmonary embolism cases per million Pfizer doses.
That works out to an excess of 98 cases of pulmonary embolism among elderly per million doses. For younger age groups, the rate of excess could be even higher than that.
Also of note is that rates often ran up to 30% above baseline — again, these are the minimums of a one-sided interval, which come from actual, point-estimated risk that was even higher than that minimum.
Reference
[FDA study showing evidence of harm from back before March of 2021] — Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older. https://www.sciencedirect.com/science/article/pii/S0264410X22014931